Determination of active ingredient in recombinant human keratinocyte growth factor 2(rhKGF-2) Liniment / 中国海洋药物

ABSTRACT

Objective To establish a method for the determination of active ingredient in recombinant human keratinocyte growth factor 2(rhKGF-2) in the liniment which matrix was mainly constituted by chitin,and to provide a feasible mensuration for quality control.Methods Based on the differential nature of antibody of rhKGF-2,ELISA was established to determine the content of rhKGF-2 in the liniment,and was confirmed by methodology.Results It was proved that other ingredients in the preparation did not disturb the mensuration of rhKGF-2;the calibration curve was linear over the range of 0～9?g?mL~(-1),the regression coefficient was 0.97,the limit of detection was 0.56?g?mL~(-1);the repeat experimentation CV% was 2.0%,and the intermediate precision CV% was(1.01%);the average recovery was 99.1%.Mensurating three batches of trial manufactures,average content for 1.62?g?mL~(-1).Conclusion This method was simple,accurate and could be used in determination of the rhKGF-2 content in this preparation.